510(k) K823388
K823388 is an FDA 510(k) premarket notification submitted by Fujisawa Electronics Co. for the device "TENS MAX". The FDA issued a decision of Substantially Equivalent on January 8, 1983. The device falls under product code GFK (Fibrinogen Determination Standards And Controls), a Class II device regulated under 21 CFR 864.7340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 1983
- Date Received
- November 15, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fibrinogen Determination Standards And Controls
- Device Class
- Class II
- Regulation Number
- 864.7340
- Review Panel
- HE
- Submission Type